Letter to Dr. Margaret Hamburg, Commissioner for the U.S. Food and Drug Administration - End Infant Drug Shortage

Letter

Today, U.S. Sen. Al Franken (D-Minn.) pressed the Food and Drug Administration (FDA) to do everything in its power to end a severe shortage of products used to treat critically ill infants.

The shortage was brought to Sen. Franken's attention by heath care providers in Minnesota. Many hospitals throughout the country have reported that the shortage is already disrupting infant care and several institutions have said they are within one to two weeks of running out of these critical products.

Sen. Franken sent a bipartisan letter signed by 13 of his Senate colleagues to FDA Commissioner Margaret Hamburg warning that the shortage is putting critically ill infants at risk of serious negative health outcomes.

"This artificial drug shortage needs to end before one more child suffers," Sen. Franken said. "I am urging the Food and Drug Administration to do everything in its power to put an end to this shortage as soon as humanly possible. I will closely monitor this situation until something is done."

Several hospitals across the country have already been forced to reduce or ration products. Products in short supply include sodium phosphate, potassium phosphate, calcium gluconate, calcium chloride, zinc, trace elements, and several others.

We appreciate the efforts of the Food and Drug Administration to address the severe shortage of several products that are commonly used at children's hospitals, including those used in total parenteral nutrition for critically ill infants. However, the ongoing shortage of these products, including sodium phosphate, potassium phosphate, calcium gluconate, calcium chloride, zinc, trace elements, and several others, is deeply concerning. Without steady doses of total parenteral nutrition, critically ill infants are at risk of serious negative health outcomes such as painful skin lesions, poor bone health, or vitamin deficiencies. We understand that at least one manufacturer of these products is currently offline and is working with you to get back on the market. We ask that you do everything in your power to get these products back on the market quickly and safely.

Shortages of products required for total parenteral nutrition are already disrupting treatment for infants. At one hospital in the Midwest, providers have been forced to reduce doses of electrolytes in children greater than 1500g in order to protect doses for neonates. At other hospitals, rationing of intravenous phosphate has forced neonates in the Cardiac Intensive Care Unit to go without this critical product, and some of these seriously ill infants are also beginning to show signs of phosphorous deficiency. Several hospitals have reported that they are within one or two weeks of running out of these products completely.

It is essential that we do all we can to prevent shortages in products that compose total parenteral nutrition so that children's hospitals can again focus on providing the best care to their patients. Thank you for your attention to this urgent and critical matter.